This IT project is part of our digitalization and optimization of our customers’ IT landscape. Through targeted measures, we promote technological progress, optimize cross-system processes and create a sustainable basis for future developments. Our IT reference projects serve as a basis for orientation. They support the reusability of tried and tested concepts as part of project implementation.
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Process migration
Project duration: 9 months
Brief description
As a consequence of a reorganisation at the customer, the product risk management process had to be optimized and mapped in the HP-ALM supported web interface WebIT.
Supplement
The activity included the process analysis of existing risk management processes. Furthermore, an optimum was to be sought that would meet the requirements of the various projects and at the same time satisfy the new regulatory requirements. To this end, existing QAPs and SOPs and the associated templates and associated IT systems were revised. For this purpose, the data model of various affected projects had to be analysed, specifications had to be collected and coordinated with the various stakeholders. The final specifications were then optimised with the developers of the IT support and tested extensively after the implementation before the final release of the system.
Subject description
The processes and the associated templates and tools have an important regulatory position. Risk Management (ISO 14971) has a fundamental role in IVD products and is the focus of every process and product audit.
IT project data
- Industries pharmaceutical industry
- Specialist tasks quality assurance, Total Quality Management, validation
- DP tasks concept
- System environments Business Intelligence
- Procedure model SA/SD (structured analysis and design)
Project period01.06.2017 - 01.03.2018
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